TriangleNCT01602380 · OUTCOME
Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months)
What was measured
PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
Analysis population: The ITT analysis set included all randomised patients.
Groups in this outcome
Fulvestrant 500 mg
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Anastrozole 1 mg
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
| Group | Source count |
|---|---|
| Fulvestrant 500 mg | 230 |
| Anastrozole 1 mg | 232 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fulvestrant 500 mg | 16.6 | Not reported | 13.83 | 20.99 | Not reported |
| Anastrozole 1 mg | 13.8 | Not reported | 11.99 | 16.59 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.637
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.999
- estimate Comment
- A hazard ratio \< 1 favours fulvestrant.
- group Description
- If the true PFS HR for comparison of fulvestrant vs. anastrozole was 0.69 (likely to correspond to a 45% prolongation of PFS) the study had 90% power to demonstrate a statistically significant difference for PFS with a one-sided type 1 error of 2.5% (two-sided 5%).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0486
- p Value Comment
- 2-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.797
- statistical Comment
- Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.637
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.999
- estimate Comment
- A hazard ratio \< 1 favours fulvestrant.
- group Description
- If the true PFS HR for comparison of fulvestrant vs. anastrozole was 0.69 (likely to correspond to a 45% prolongation of PFS) the study had 90% power to demonstrate a statistically significant difference for PFS with a one-sided type 1 error of 2.5% (two-sided 5%).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0486
- p Value Comment
- 2-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.797
- statistical Comment
- Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.83
- upper Limit
- 20.99
- value
- 16.6
- group Id
- OG001
- lower Limit
- 11.99
- upper Limit
- 16.59
- value
- 13.8
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 232
- units
- Participants
- description
- PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
- id
- OG000
- title
- Fulvestrant 500 mg
- description
- Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
- id
- OG001
- title
- Anastrozole 1 mg
- param Type
- MEDIAN
- population Description
- The ITT analysis set included all randomised patients.
- reporting Status
- POSTED
- time Frame
- Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months)
- title
- Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice